510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K910038Substantially Equivalent

Lorenz Ultra-Micro Titanium Osteosynthesis System

Biomet Microfixation, Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910038 is the FDA 510(k) clearance record for LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM, a class II device, cleared for Walter Lorenz Surgical, Inc. on under FDA product code JEY (Plate, Bone). FDA records list 86 510(k) clearances for BIOMET MICROFIXATION, from to . As of , FDA records show no recalls naming K910038.

Clearance record

Decision date
Received
(47 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Walter Lorenz Surgical, Inc. P.O. Box 18009, Jacksonville FL
Third party review
No

Clearances, product code JEY

Trailing 12 months
4 clearances under product code JEY in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260
November 20260